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Brain oxygen monitoring may boost recovery after severe head trauma

NCT ID NCT03754114

Disease control Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two standard methods for treating severe traumatic brain injury in the ICU. One method monitors only brain pressure, while the other also tracks brain oxygen levels. About 1,094 patients will take part to see which approach leads to better recovery and survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,094 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2019

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Non-penetrating traumatic brain injury * Glasgow Coma Scale (GCS) 3-8 measured off paralytics * Glasgow Coma Scale motor score \< 6 if endotracheally intubated * Evidence of intracranial trauma on CT scan * Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital * Able to place intracranial probes and randomize within 12 hours from injury * Age greater than or equal to 14 years Exclusion Criteria: * Non-survivable injury * Bilaterally absent pupillary response in the absence of paralytic medication * Contraindication to the placement of intracranial probes * Treatment of brain tissue oxygen values prior to randomization * Planned use of devices which may unblind treating physicians to brain tissue hypoxia * Systemic sepsis at screening * Refractory hypotension * Refractory systemic hypoxia * PaO2/FiO2 ratio \< 150 * Known pre-existing neurologic disease with confounding residual neurological deficits * Known inability to perform activities of daily living (ADL) without assistance prior to injury * Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments * Pregnancy * Prisoner * On EFIC Opt-Out list as indicated by a bracelet or medical alert

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Hypoxia, Brain traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain injuries, traumatic

Contacts and locations

Locations

  • Ben Taub General Hospital

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CIUSSS-NIM Hopital du Sacre - Coeur de Montreal

    Montreal, H4J 1C5, Canada

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cooper University Hospital

    Camden, New Jersey, 08103, United States

  • Detroit Receiving Hospital

    Detroit, Michigan, 48201, United States

  • Duke University Hospital

    Durham, North Carolina, 27710, United States

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

  • Harborview Medical Center

    Seattle, Washington, 98104, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48201, United States

  • Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Maine Medical Center

    Portland, Maine, 04102, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02128, United States

  • NYP Columbia University Medical Center

    New York, New York, 10032, United States

  • NewYork-Presbyterian Queens Hospital

    Flushing, New York, 11355, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Oregon Health & Science University Hospital

    Portland, Oregon, 97239, United States

  • Parkland Hospital

    Dallas, Texas, 75235, United States

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095-7436, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • San Francisco General Hospital

    San Francisco, California, 94143, United States

  • St. Michaels Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • St. Vincent Hospital

    Indianapolis, Indiana, 46260, United States

  • Stanford University Medical Center

    Palo Alto, California, 94305, United States

  • Strong Memorial Hospital

    Rochester, New York, 14642, United States

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UC Davis Medical Center

    Sacramento, California, 95817, United States

  • UF Health Shands Hospital

    Gainesville, Florida, 32608, United States

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta, T2N 2T9, Canada

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of New Mexico Hospital

    Albuquerque, New Mexico, 87131, United States

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514, United States

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229, United States

  • University of Utah Healthcare

    Salt Lake City, Utah, 84132, United States

  • VCU Medical Center

    Richmond, Virginia, 23298, United States

  • WVU Healthcare Ruby Memorial Hospital

    Morgantown, West Virginia, 26506, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.